QA and Compliance Manager

Rovia Clinical Research

5h•Remote

About The Position

The QA and Compliance Manager ensures compliance with regulatory standards and quality management practices, and oversees the execution of clinical studies according to established protocols and contractual obligations. This fully remote position requires occasional site travel (20%); candidates must be located in the Eastern or Central time zones.

Requirements

Well-versed in the conduct of clinical trials.
Subject matter expertise in ICH/GCP, regulatory requirements, and FDA and HIPAA policies and practices.
Experience with FDA inspections and sponsor audits.
Bachelor's degree in a related field or relevant experience.
At least 2 years of CRC experience.
At least 3 years of quality specialist experience.
1–2 years of quality management experience.
Must be located in the Eastern or Central time zones.

Nice To Haves

CCRC, ACRP, or compliance certification.

Responsibilities

Implement and maintain quality assurance policies and procedures.
Conduct regular audits of clinical trial activities to ensure compliance with regulatory requirements and internal standards.
Oversee adverse event reporting and compliance documentation.
Supervise the management and implementation of Standard Operating Procedures (SOPs) to support compliance and operational efficiency.
Establish, measure, and report on quality indicators.
Train staff on quality assurance practices and compliance regulations.
Collaborate with cross-functional teams to address quality-related issues and implement corrective actions.
Support site staff during sponsor monitoring, audit activities, and health authority inspections, including preparation, hosting, and resolution of items.
Serve as a point of contact for regulatory agencies during inspections and audits.
Lead investigations into quality deviations and develop action plans to prevent recurrence.
Perform other duties as assigned.